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OpenTrials
Completed

NCT Number: NCT05297968

Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

an open label,balanced,randomized,two-treatment,two-period,two-sequence,single dose,crossover,oral bioequivalence Study of oseltamivir phosphate for oral suspension in healthy ,adult,human subjects under fasted/fed conditions.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

About this study

72 healthy adult subjects will be enrolled and randomized in the study.In each period,total 21 venous blood samples (3ml each)will be collected at 0h,10min,20min,30min,45min,1h,1.25h,1.5h,1.75h,2h,2.25h,2.5h,3h,3.5h,4h,4.5h,5h,6h,8h,12h,24h,36h.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) Subjects are able to give the signed ICF before the study, and fully understand the study content, process and possible adverse reactions; 2) Subjects are able to complete the study in compliance the study in compliance with the protocol; 3) Subjects (including male subjects) agree to adopt effective contraceptive methods and not plan to get pregnant or to donate sperm or ovum from 14 days before screening to 3 months after study completion; 4) Healthy male and female subjects above 18 years of age ( inclusive); 5) Male subjects who are at least 50 kg and female subjects who are at least 45 kg, with a Body Mass Index (BMI)= Weight/Height2 (kg/m2) between 19.0-26.0 kg/m2 (both inclusive);

Exclusion criteria

  • History of specific allergies (asthma, etc.), allergies (such as those who are allergic to two or more drugs, foods such as milk or pollen), or hypersensitivity to Oseltamivir Phosphate or any excipients or related class of drugs
  • People with rare hereditary galactose intolerance or fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase deficiency;
  • No history of cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc.;
  • History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption;
  • History of surgery within 3 months prior to first dosing;
  • 5 or more cigarettes per day on average within 3 months before the screening;
  • Use of any drugs within 14 days prior to dosing

Treatment and study plan

Oseltamivir Phosphate For Oral Suspension/Tamiflu

Drug

the subjects randomly received single oral administration of Oseltamivir Phosphate For Oral Suspension/Tamiflu 75mg (6mg/ml,12.5ml)

Other names: tamiflu

Oseltamivir Phosphate For Oral Suspension

Drug

the subjects randomly received single oral administration of Oseltamivir Phosphate For Oral Suspension 75mg (6mg/ml,12.5ml)

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: up to 1 year

    Evaluation of Peak Plasma Concentration (Cmax)

  2. Area under the plasma concentration versus time curve (AUC0-t)

    Time frame: up to 1 year

    Evaluation of Area under the plasma concentration versus time curve (AUC0-t)

  3. Area under the plasma concentration versus time curve (AUC0-∞)

    Time frame: up to 1 year

    Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)

  4. Bioequivalence

    Time frame: up to 1 year

    Analysis of variance (ANOVA) was performed after logarithmic conversion of main pharmacokinetic parameters (Cmax, AUC) to calculate 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters of the two preparations, and equivalence comparison was conducted. The equivalent interval was set to 80.00%~125.00%

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: up to 1 year

    Collection of adverse events

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 28, 2022
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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